BEnefit of HYpnosis on Pain During Stitches in Emergency Room: The BE-HYPER Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Heart rate variability
研究概览
简要总结
Suturing is a daily practice in the emergency department, but it can be painful and stressful for patients. Hypnosis is increasingly used as a complement to the usual painkillers. The aim of our study was to investigate the impact of hypnosis on stitch placement in emergency department patients presenting with lacerations assessed by heart rate variability.
详细描述
The aim of this randomized, controlled, single-center, prospective study is to evaluate the impact of hypnosis during stitching in emergency department patients presenting with a laceration assessed by heart rate variability.
All patients with eligibility criteria will be included if the patient gave his written consent.
Patients will be randomized to one of two arms: (1) Hypnosis or (2) Standard Of Care (SOC) A heart rate monitoring belt will be fitted to the patient for both groups. The patient will be asked to complete a self-assessment questionnaire on pain and stress, as well as socio-demographic parameters.
A blood sample will be collected and the heart rate and blood pressure will be measured.
Stitches will be taken with or without hypnosis, and after 30 minutes, the pain and stress self-assessment questionnaire will again be completed by the patient, and a new blood test will be taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •Admitted in the emergency department of Clermont-Ferrand University Hospital
- •Stitchable wound
- •Patient's agreement
排除标准
- •Pregnancy
- •Breast feeding
- •Refusal to participate
- •Patient not able to participate
- •Patients under guardianship, curatorship, deprived of liberty or safeguard of justice.
- •History of cardiac rhythm disorders (atrial fibrillation, pacemaker)
- •Psychotic disorder
- •Age < 18 years old
- •Surgery needed
- •Patients who don't speak French
- •Wound of the eyelids, nose, ears or mouth
- •Deaf patients
- •Patients without a social security coverage
- •Nitrous oxyde use
- •Substance abuse
- •Head trauma with GSC ≤ 14
- •Patient with endocrine diseases on the cortisol axis
研究组 & 干预措施
Standard of Care
Stitches will be performed without hypnosis as usual
Hypnosis
Patients will be hypnotized by a trained person before suturing.
干预措施: Hypnosis (Other)
结局指标
主要结局
Heart rate variability
时间窗: Hour 0
The heart rate variability will be measured using Bittium Faros
次要结局
- Impact of the depth of the wound on pain and stress(Hour 0; Hour 0+30 minutes)
- Impact of location of the wound on variability of heart frequency(Hour 0; Hour 0+30 minutes)
- Evaluation of stress biomarkers in blood samples(Hour 0; Hour 0+30 minutes)
- Evaluation of blood pressure(Hour 0; Hour 0+30 minutes)
- Evaluation of heart rate(Hour 0; Hour 0+30 minutes)
- Impact of sociodemographics parameters on pain and stress(Hour 0; Hour 0+30 minutes)
- Impact of the length of the wound on pain and stress(Hour 0; Hour 0+30 minutes)
- Impact of location of the wound on pain and stress(Hour 0; Hour 0+30 minutes)
- Impact of the length of the wound on variability of heart frequency(Hour 0; Hour 0+30 minutes)
- Changes on visual analog scale of pain and stress(Hour 0; Hour 0+30 minutes)